Tantipong 2008.
Study characteristics | ||
Methods | Study design: single‐centre RCT with 2 parallel groups Location: Thailand Number of centres: 1 tertiary care university hospital Study period: January 2006 through March 2007 Funding source: Thailand Research Fund and Faculty of Medicine Siriraj Hospital |
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Participants | Inclusion criteria: eligible patients were adults aged ≧ 18 years who were hospitalised in intensive care units (36 beds) or general medical wards (240 beds) at Siriraj Hospital and who received mechanical ventilation. Exclusion criteria: patients who had pneumonia at enrolment or who had a chlorhexidine allergy Number randomised: 207 Number evaluated: 207 (110 participants received mechanical ventilation for > 48 hours) ‐ Experimental group: n = 102; age: 56.5 ± 20.1; M/F: 50/52; mean APACHE II score: 16.7 ± 7.9 ‐ Control group: n = 105; age: 60.3 ± 19.1; M/F: 51/54; mean APACHE II score: 18.2 ± 8.1 Participants' demographic characteristics between groups did not differ significantly. |
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Interventions |
Comparison: toothbrush + chlorhexidine vs toothbrush + placebo Experimental group (n = 102): received oral care 4 times a day with brushing the teeth, suctioning any oral secretions, and rubbing the oropharyngeal mucosa with 15 mL of a 2% chlorhexidine solution, until their endotracheal tubes were removed. Control group (n = 105): same oral care procedure with normal saline solution |
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Outcomes | 1. Incidence of VAP 2. Number of cases of VAP per 1000 ventilator days 3. Incidence of VAP for participants who received mechanical ventilation for > 2 days 4. Overall mortality 5. Mean days of mechanical ventilation (mean ± SD) 6. Rate of irritation of oral mucosa |
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Notes | Sample size calculation: estimated that 108 participants required in each group to give 80% power to detect a 50% decrease in VAP with 5% Type 1 error | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "...randomized...by stratified randomization according to sex and hospital location of eligible patient" |
Allocation concealment (selection bias) | Unclear risk | Not mentioned and probably not done |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded as chlorhexidine solution had different odour and taste from saline |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The assessors who determined whether a participant developed pneumonia were unaware of the participant's study group assignment. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | All randomised participants included in outcome evaluation but only 53% of participants on ventilators for > 2 days and therefore at risk of VAP |
Selective reporting (reporting bias) | Unclear risk | Planned outcome VAP but not all participants at risk and information unclear. Mortality reported |
Other bias | Unclear risk | Only 60% of study participants received ventilation in ICU and only 53% of participants received mechanical ventilation for > 48 hours. Likely that nursing care protocols were different in general medical wards compared to ICUs |